3739632
Last Update Posted: 2020-10-30
Recruiting has ended
All Genders accepted | 18 Years-65 Years |
240 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets
The objective of this study is to evaluate the safety and efficacy of Hypidone Hydrochloride tablets in treatment of patients with major depressive disorder (MDD) by evaluating the change of MADRS total scores from baseline to week 6.
A total of 240 major depressive disorder (MDD) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by DSM-5 will be recruited, Eligible patients will be randomized with a 1:1:1:1 ratio into the 4 treatment arms to receive either Hypidone Hydrochloride tablets or placebo, and will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessment.
The subjects will accept the drug treatment twice daily orally for 6 weeks. During the treatment follow up will occur at 8±1 days after treatment, 15±1 days after treatment, 29±2 days after treatment , 43±2 days after treatment to evaluate the safety and efficacy of the drug.
Eligibility
Relevant conditions:
Major Depressive Disorder
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov